CN103319592B - 通过热处理获得IgG组合物的方法 - Google Patents

通过热处理获得IgG组合物的方法 Download PDF

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Publication number
CN103319592B
CN103319592B CN201310090730.0A CN201310090730A CN103319592B CN 103319592 B CN103319592 B CN 103319592B CN 201310090730 A CN201310090730 A CN 201310090730A CN 103319592 B CN103319592 B CN 103319592B
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China
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igg
solution
concentration
protein
polymer
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Chinese (zh)
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CN103319592A (zh
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佩雷·里斯托尔德巴尔特
萨尔瓦多尔·格兰沙加蒙
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Grifols SA
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Grifols SA
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39516Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
    • A61K39/39525Purification
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Analytical Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Confectionery (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
CN201310090730.0A 2012-03-20 2013-03-20 通过热处理获得IgG组合物的方法 Active CN103319592B (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES201230413 2012-03-20
ES201230413A ES2381828B1 (es) 2012-03-20 2012-03-20 PROCEDIMIENTO PARA OBTENER UNA COMPOSICION DE IgG MEDIANTE TRATAMIENTO TERMICO

Publications (2)

Publication Number Publication Date
CN103319592A CN103319592A (zh) 2013-09-25
CN103319592B true CN103319592B (zh) 2020-03-03

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CN201310090730.0A Active CN103319592B (zh) 2012-03-20 2013-03-20 通过热处理获得IgG组合物的方法

Country Status (21)

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US (1) US9200032B2 (enExample)
EP (1) EP2641912B1 (enExample)
JP (2) JP6048936B2 (enExample)
KR (1) KR101840064B1 (enExample)
CN (1) CN103319592B (enExample)
AR (1) AR090337A1 (enExample)
AU (1) AU2013201853B2 (enExample)
BR (1) BR102013006411A2 (enExample)
CA (1) CA2809513C (enExample)
CL (1) CL2013000688A1 (enExample)
ES (2) ES2381828B1 (enExample)
HU (1) HUE027915T2 (enExample)
IL (1) IL225197A (enExample)
MX (1) MX339268B (enExample)
MY (1) MY165024A (enExample)
PL (1) PL2641912T3 (enExample)
PT (1) PT2641912T (enExample)
RU (1) RU2636049C2 (enExample)
SG (1) SG193738A1 (enExample)
TW (1) TWI554283B (enExample)
UY (1) UY34679A (enExample)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2990033A1 (fr) * 2014-08-26 2016-03-02 Carlina Technologies Procédé de préparation de nanoprécipites de peptide ou protéine de faible poids moléculaire
HUE042984T2 (hu) * 2015-08-31 2019-07-29 Inst Grifols S A Eljárás immunglobulinok elõállítására
RU2708394C2 (ru) * 2016-09-26 2019-12-06 Институто Грифольс,С.А. Способ получения иммуноглобулинов
IL277797B1 (en) * 2018-04-12 2024-11-01 Amgen Inc Methods for making stable protein compositions
CN112557643B (zh) * 2019-09-26 2023-04-14 菲鹏生物股份有限公司 变性IgG和类风湿因子免疫抗原及制备方法
CN112858671B (zh) * 2019-11-27 2022-12-27 菲鹏生物股份有限公司 制备类风湿因子检测试剂的方法、类风湿因子检测试剂、试剂盒和检测方法

Citations (3)

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Publication number Priority date Publication date Assignee Title
ES2091161A1 (es) * 1995-04-12 1996-10-16 Grifols Grupo Sa Procedimiento para la produccion de gammaglobulina intramascular inactivada por pasteurizacion.
CN1201694A (zh) * 1998-06-25 1998-12-16 成都蜀阳制药厂 无保护剂双重病毒灭活制备静注免疫球蛋白工艺
CN1311797A (zh) * 1998-06-09 2001-09-05 斯塔滕斯血清研究所 生产用于静脉给药的免疫球蛋白和其他免疫球蛋白产品的方法

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US514375A (en) 1894-02-06 miller
CA1064396A (en) 1975-02-18 1979-10-16 Myer L. Coval Fractional precipitation of gamma globulin with polyethylene glycol
US4165370A (en) 1976-05-21 1979-08-21 Coval M L Injectable gamma globulin
EP0035204B2 (en) 1980-03-05 1991-05-22 Miles Inc. Pasteurized therapeutically active protein compositions
US4396608A (en) 1981-08-24 1983-08-02 Cutter Laboratories Intravenously injectable immune serum globulin
ES506679A0 (es) 1981-10-29 1982-08-16 Green Cross Corp Un procedimiento para preparar una immunoglobulina adecuada para inyeccion intravenosa
US4540573A (en) 1983-07-14 1985-09-10 New York Blood Center, Inc. Undenatured virus-free biologically active protein derivatives
JPH0825902B2 (ja) 1985-02-21 1996-03-13 株式会社ミドリ十字 γ−グロブリンの加熱処理方法
JPH0662436B2 (ja) 1986-05-19 1994-08-17 株式会社ミドリ十字 静注用免疫グロブリン製剤の製造方法
CA1310267C (en) 1986-07-09 1992-11-17 Yutaka Hirao Process for heat treating chemically unmodified _-globulin
JP2547556B2 (ja) 1987-02-06 1996-10-23 株式会社 ミドリ十字 r−グロブリンの液状製剤
US4876241A (en) * 1987-05-22 1989-10-24 Armour Pharmaceutical Company Stabilization of biological and pharmaceutical products during thermal inactivation of viral and bacterial contaminants
AT403989B (de) * 1996-09-16 1998-07-27 Immuno Ag Verfahren zur herstellung eines plasmaprotein-hältigen arzneimittels
US5886154A (en) 1997-06-20 1999-03-23 Lebing; Wytold R. Chromatographic method for high yield purification and viral inactivation of antibodies
UA64742C2 (uk) * 1997-12-24 2004-03-15 Альфа Терапевтик Корпорейшн СПОСІБ ОДЕРЖАННЯ РОЗЧИНУ <font face="Symbol">g</font>-ГЛОБУЛІНУ, ПРИЗНАЧЕНОГО ДЛЯ ВНУТРІШНЬОВЕННОГО ВВЕДЕННЯ, І ПРОДУКТ, ЩО ОДЕРЖУЄТЬСЯ У ЦЕЙ СПОСІБ (ВАРІАНТИ)
US6281336B1 (en) * 1998-06-09 2001-08-28 Statens Serum Institut Process for producing immunoglobulins for intravenous administration and other immunoglobulin products
ES2184594B1 (es) * 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
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US8796430B2 (en) * 2010-05-26 2014-08-05 Baxter International Inc. Method to produce an immunoglobulin preparation with improved yield

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2091161A1 (es) * 1995-04-12 1996-10-16 Grifols Grupo Sa Procedimiento para la produccion de gammaglobulina intramascular inactivada por pasteurizacion.
CN1311797A (zh) * 1998-06-09 2001-09-05 斯塔滕斯血清研究所 生产用于静脉给药的免疫球蛋白和其他免疫球蛋白产品的方法
CN1201694A (zh) * 1998-06-25 1998-12-16 成都蜀阳制药厂 无保护剂双重病毒灭活制备静注免疫球蛋白工艺

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
Preparation, purification and virus inactivation of intravenous immunoglobulin from human plasma;Aghaie A;《Hum Antibodies》;20100131;第19卷(第1期);1-6 *

Also Published As

Publication number Publication date
CA2809513A1 (en) 2013-09-20
EP2641912A1 (en) 2013-09-25
RU2013112276A (ru) 2014-09-27
JP2013194054A (ja) 2013-09-30
HK1185625A1 (en) 2014-02-21
MX2013002910A (es) 2013-09-19
SG193738A1 (en) 2013-10-30
US20140113355A1 (en) 2014-04-24
AU2013201853B2 (en) 2014-07-03
ES2381828B1 (es) 2012-11-16
EP2641912B1 (en) 2016-06-15
IL225197A (en) 2017-06-29
MY165024A (en) 2018-02-28
JP6048936B2 (ja) 2016-12-21
KR20130106792A (ko) 2013-09-30
PL2641912T3 (pl) 2016-11-30
TWI554283B (zh) 2016-10-21
CL2013000688A1 (es) 2014-02-28
CA2809513C (en) 2016-09-27
AU2013201853A1 (en) 2013-10-10
JP2016199586A (ja) 2016-12-01
ES2590045T3 (es) 2016-11-17
KR101840064B1 (ko) 2018-03-19
ES2381828A1 (es) 2012-06-01
CN103319592A (zh) 2013-09-25
TW201343179A (zh) 2013-11-01
BR102013006411A2 (pt) 2015-06-09
MX339268B (es) 2016-05-18
RU2636049C2 (ru) 2017-11-17
PT2641912T (pt) 2016-08-12
IL225197A0 (en) 2013-06-27
AR090337A1 (es) 2014-11-05
US9200032B2 (en) 2015-12-01
UY34679A (es) 2013-10-31
HUE027915T2 (en) 2016-11-28

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